NCT00658099已完成不适用
Change in Weight on Insulin Detemir (Levemir®) or Isophane (NPH) Insulin (Insulatard®) in Patients With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 699
- 试验地点
- 1
- 主要终点
- Change in weight
研究概览
简要总结
This trial is conducted in Europe. The aim of this observational study is to evaluate the change in weight in type 2 diabetes patients using Levemir® or Insulatard® under normal clinical practice conditions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •HbA1c greater than 7.0% and/or hypoglycaemia
- •variable FBG and/or weight increase
- •the selection of the subjects will be at the discretion of the participating physician
排除标准
- •non-type 2 diabetes
- •current treatment with Levemir® or Insulatard®
- •hypersensitivity to Levemir® or Insulatard® or to any of the excipients
- •women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months
研究组 & 干预措施
A
干预措施: insulin detemir (Drug)
B
干预措施: insulin NPH (Drug)
结局指标
主要结局
Change in weight
时间窗: after 6 months of treatment
次要结局
- The effect on metabolic control assessed by the changes in glycaemic parameters: HbA1c and blood glucose values(after 6 months of treatment)
- The incidence of hypoglycaemic events(after 6 months of treatment)
- Safety parameters by collecting (serious) adverse drug reactions, pregnancies and technical complaints.(after 6 months of treatment)
- The general well-being by using the WHO-5 well-being questionnaire.(after 6 months of treatment)
- The treatment satisfaction of subjects treated with insulin detemir or NPH insulin by using insulin treatment satisfaction questionnaire(after 6 months of treatment)
- The satisfaction of physicians who treat the subjects with either insulin detemir or NPH insulin by using 4 questions, which are included in CRF, at the final visit.(after 6 months of treatment)
研究者
研究点 (1)
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